Non-Operative Management and Following Immunotherapy for Colorectal Cancer and Other GI Cancers (NOMIC)
2026年6月15日 更新者：Xiaokang Lei、Peking University Cancer Hospital & Institute
Non-Operative Management and Following Immunotherapy for Colorectal Cancer and Other GI Cancers (NOMIC Trial)
This is a single-center, bidirectional (retrospective and prospective) registry study aimed at evaluating the safety and efficacy of Non-Operative Management (NOM) and Organ-Preserving Functional Surgery (OPFS) in patients with mismatch repair-deficient/microsatellite instability-high (dMMR/MSI-H) or POLE-mutated gastrointestinal (GI) cancers who received neoadjuvant immunotherapy.Patients achieving a clinical complete response (cCR) or near-cCR may undergo a "Watch & Wait" (W&W) strategy, while those with near-cCR or non-cCR ($\le ymrT2N0$) may undergo local excision (LE) or endoscopic resection (ESD/EMR).
Patients undergoing radical operation (RO) will serve as the control cohort to compare oncological outcomes and safety data.
研究概览
研究类型
观察性的
注册 (估计的)
50
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Lin Wang Prof., M.D.
- 电话号码：13910975011
- 邮箱：wanglinmd@foxmail.com
研究联系人备份
- 姓名：Xiaokang Lei Dr., M.D.
学习地点
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Haidian District
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Beijing、Haidian District、中国、100142
- Peking University Cancer Hospital
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接触：
- Xiaokang Lei Dr., M.D.
- 电话号码：18811181993
- 邮箱：lxkpku@163.com
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
不
取样方法
非概率样本
研究人群
Patients with mismatch repair-deficient/microsatellite instability-high (dMMR/MSI-H) or POLE-mutated gastrointestinal (GI) cancers who received neoadjuvant immunotherapy.
描述
Inclusion Criteria:
Retrospective Cohort Inclusion Criteria
- Pathologically confirmed gastrointestinal malignancy determined as MSI-H/dMMR or POLE mutation, and initially resectable.
- Completed prior immunotherapy.
- No evidence of distant metastasis.
- Managed with W&W, LE, endoscopic surgery, or radical operation after treatment.
Prospective Cohort Inclusion Criteria
- Pathologically confirmed gastrointestinal malignancy determined as MSI-H/dMMR or POLE mutation, and initially resectable.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- Immunotherapy status: naive, currently receiving, or completed treatment, and evaluated by the PKUCH-NOMIC research group as cCR/near-cCR or Non-cCR (≤ ymrT2N0).
- No evidence of distant metastasis.
- Absence of emergencies requiring immediate surgery (e.g., hemorrhage, perforation, obstruction).
Exclusion Criteria:
- Recurrent gastrointestinal tumors.Initial presence of unresectable distant metastases.
- Serum creatinine > 1.5 times upper limit of normal (ULN).
- History of pelvic radiation therapy.Inability to tolerate MRI examinations.
- History of other malignancies within the past 5 years with a survival rate significantly lower than the historical rectal cancer survival data of this center (except adequately treated basal cell carcinoma, cutaneous squamous cell carcinoma, small renal cell carcinoma, breast cancer, and papillary thyroid carcinoma).
- Arterial thromboembolic events within the past 6 months (e.g., angina, myocardial infarction, transient ischemic attack [TIA], cerebral vascular accident [CVA]).
- Prior receipt of other types of investigational anti-tumor therapies.
- Pregnant or lactating women.
- Concomitant diseases or mental health conditions that may interfere with study participation.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
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Experimental Cohort (NOM)
Patients achieving a clinical complete response (cCR) or near-cCR may undergo a "Watch & Wait" (W&W) strategy, while those with near-cCR or non-cCR (≤ymrT2N0$) may undergo local excision (LE) or endoscopic resection (ESD/EMR).
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Patients achieving a clinical complete response (cCR) or near-cCR may undergo a "Watch & Wait" (W&W) strategy, while those with near-cCR or non-cCR (≤ymrT2N0) may undergo local excision (LE) or endoscopic resection (ESD/EMR).
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Control arm
Patients undergoing radical operation (RO) will serve as the control cohort to compare oncological outcomes and safety data.
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Patients undergoing radical operation (RO) will serve as the control cohort to compare oncological outcomes and safety data.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Organ Preservation Rate
大体时间：3 years after the completion of neoadjuvant immunotherapy.
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The proportion of patients successfully managed with NOM without the need for supplementary radical surgery, loss of organ function, or a permanent stoma (specifically for rectal cancer patients).
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3 years after the completion of neoadjuvant immunotherapy.
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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总生存（OS）
大体时间：最多5年。
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从任何原因开始的治疗开始到死亡的时间。
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最多5年。
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Surgical Safety and Postoperative Complications
大体时间：3 years after the completion of neoadjuvant immunotherapy.
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Incidence and severity of perioperative complications classified by the Clavien-Dindo grading system, comparing RO, LE, and endoscopic resection (ESD/EMR).
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3 years after the completion of neoadjuvant immunotherapy.
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Distribution of Pathological Response (RO Group Only)
大体时间：At the time of radical surgery (typically 4-12 weeks post-immunotherapy).
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Percentage of patients achieving ypCR, ypTisN0, ypT1-2N0, and ypT3+ in the radical surgery cohort to characterize pathological response after immunotherapy.
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At the time of radical surgery (typically 4-12 weeks post-immunotherapy).
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Local Regrowth Rate
大体时间：Regular follow-up every 3-6 months for up to 3 years.
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The proportion of patients experiencing local tumor regrowth in the W&W group or after local/endoscopic excision.
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Regular follow-up every 3-6 months for up to 3 years.
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Disease-Free Survival (DFS)
大体时间：Up to 5 years from enrollment/treatment initiation.
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Time from the initiation of neoadjuvant immunotherapy to the first documentation of disease recurrence (local, regional, or distant), progression, or death from any cause, comparing the NOM/OPFS group with the RO group.
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Up to 5 years from enrollment/treatment initiation.
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年6月15日
初级完成 (估计的)
2029年6月15日
研究完成 (估计的)
2030年10月15日
研究注册日期
首次提交
2026年6月15日
首先提交符合 QC 标准的
2026年6月15日
首次发布 (实际的)
2026年6月18日
研究记录更新
最后更新发布 (实际的)
2026年6月18日
上次提交的符合 QC 标准的更新
2026年6月15日
最后验证
2026年6月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.